Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074703
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/31/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/08/2014 SUPPL-10 Labeling-Medication Guide

Label is not available on this site.

02/15/2011 SUPPL-9 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/074703s009ltr.pdf
02/17/2011 SUPPL-8 Labeling

Label is not available on this site.

09/15/2009 SUPPL-7 Labeling, REMS-Proposal Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/074703s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/074703Orig1s007.pdf
06/30/2009 SUPPL-6 REMS-Proposal, Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/074703Orig1s006.pdf
05/16/2012 SUPPL-5 Labeling

Label is not available on this site.

08/18/2003 SUPPL-4 Labeling

Label is not available on this site.

07/12/2002 SUPPL-3 Labeling

Label is not available on this site.

12/20/2001 SUPPL-2 Labeling

Label is not available on this site.

09/21/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

METOCLOPRAMIDE HYDROCHLORIDE

SOLUTION;ORAL; EQ 5MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 071402 ANI PHARMS
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 072744 PHARM ASSOC
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 075051 VISTAPHARM
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 074703 WOCKHARDT BIO AG

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